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On Friday, the U.S. Food and Drug Administration told 23andMe CEO Anne Wojcicki that her company “must immediately discontinue marketing the [Personal Genome Service].”

For $99, 23andMe will analyze the DNA in a saliva sample for genetic traits related to ancestry information, physical characteristics, disease risk, and drug response. The health-related information is what concerns the FDA. The agency says that customers may make health decisions such as prophylactic breast removal surgery as a result of 23andMe’s report on their genetic risk for breast cancer. The problem, writes the FDA, is that the company has not provided the data to prove that the tests work, so consumers may make major health decisions based on faulty results.

Over a year ago, 23andMe announced that it was working with the FDA to get approval on at least some of the health traits in its service (see “Personal Genetics Company Seeks Regulatory Approval”). At the time, the company said it was looking forward to a collaborative process with the agency in the new territory of consumer genetics. So it was a bit surprising to read in the FDA’s letter that the company has not provided the agency with the data the regulatory agency requested in January to support marketing the health portions of the personal genomics test.

So what has 23andMe been doing instead? For one, they kicked off a large marketing campaign, which seems to have stirred up some ire in the FDA. From the agency’s letter to Wojcicki:

“[The] FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the [Personal Genome Service’s] uses and consumer base without obtaining marketing authorization from FDA.”

23andMe acknowledges that it has been remiss in responding to the FDA, but doesn’t say much else:

“We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

 

This post was updated 1:30 pm EST with comment from 23andMe.

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